Veterinary Medicines

The Department of Agriculture, Food and the Marine (the Department) is responsible for the implementation of controls in relation to veterinary medicines the purpose of which is to safeguard public health and animal health and welfare. The European Communities (Animal Remedies) (No 2) Regulations 2007 (S.I. 786 of 2007) sets down a legislative basis for the licensing of veterinary medicines and controls on their distribution. Under this regime, the Health Products Regulatory Authority (HPRA) are the national licensing authority responsible for veterinary medicines (animal remedies), while the Department is responsible for the licensing of premises engaged in the commercial distribution of veterinary medicines. All animal remedies intended for use must be authorised in the State and can only be used in accordance with the conditions attached to the product authorisation.

There are currently, over 1,750 individual products licensed in accordance with the requirements of EU legislation. In addition, there are 96 wholesale and just under 800 retail premises regulated and licensed in accordance with the European Communities (Animal Remedies) (No 2) Regulations 2007 (S.I. 786 of 2007). These premises have been inspected by the Department to ensure that they reach the required standard.

The manufacture, distribution and sale of medicated feedingstuffs and intermediate products is also subject to licensing by the Minister under the European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations, 1994 as amended by the European Communities (Animal Remedies and Medicated Feedingstuffs) (Amendment) Regulations, 2003. The use of medicated feedingstuffs is prohibited except under and in accordance with the terms of a veterinary written direction issued by a registered veterinary practitioner. Medicated pre-mixes must be authorised by the HPRA. There are approximately 20 licensed medicated feed manufacturers and 48 home mixers licensed to manufacture medicated feed in Ireland.